Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1605-2025·Announced 2025-04-23

Medline Convenience Kit NAIL PACK Sterile Packaging Seal Defect Recall

Medline is recalling select NAIL PACK sterile convenience kits (Model SUT15830A, Lot 24IBR642) due to potential open or weak seals on breather pouches used for product packaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall (per agency classification) with no reported illnesses or injuries. The hazard is a packaging defect that poses a potential sterility compromise, which is a manufacturing/labeling-class issue rather than an imminent health threat with documented harm.

Plain-English summary

Medline Industries, LP is recalling select NAIL PACK sterile convenience kits (Model Number SUT15830A, Lot Number 24IBR642) due to a potential for open or weak seals on purchased breather pouches used for packaging of these kits.

The affected kits were distributed worldwide, including nationwide across the United States and to Canada, Mexico, Panama, and the Virgin Islands. The defective packaging may compromise the sterile integrity of the products.

Persons who have purchased or received these kits should stop using them and contact Medline Industries, LP for instructions on return or replacement. Healthcare facilities and distributors should verify whether they have received affected lot numbers and quarantine product accordingly.

The recalled product

Product: Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Sterile Surgical Kit / Packaging
Hazard: packaging-defect
sterility-compromise
Affected units: 6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

1) SUT15830A
UDI-DI: 10653160996750(each)
40653160996751(case)
Lot Number: 24IBR642

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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